A Systematic Review of the Inclusion and Analysis of Older Adults in Randomized Controlled Trials

Older adults account for the major share of health care utilization and expenditures. Yet adults over a certain age and those who are frail are excluded from clinical trials. This means that clinicians and policy-makers make treatment decisions on evidence from trials with primarily middle age adults who often do not represent the older patient.

To assess the representation and analysis of older adults in major clinical research, these researchers reviewed randomized controlled trials (RTCs) published in five high-profile journals in 2007.

The 109 articles examined covered a range of subspecialties with cardiovascular (40%) and oncologic (20%) the most common conditions. The trials evaluated a drug (68%), or a device, procedure or surgery (21%). Most were conducted in multiple centers (86%) and were funded fully or partially by industry (71%).

The mean age of trial participants was 61 years old. Some 20 percent of RTCs excluded individuals over a certain age. Nearly half without an age limit employed eligibility criteria that could disproportionately exclude older adults with complex health status.

The authors suggest steps that research investigators can take to increase the relevance of study results for older patients. They also propose guidelines to improve the quality of age-specific subgroup analysis.